MCPHS University

School of Pharmacy Worcester/Manchester

PPW 360 Pharmacy Law
Fall, 2017 Course Syllabus
*Syllabus is subject to change without prior notice*

COURSE INFORMATION
Class schedule: Wednesdays, 3:05-4:55pm
Class location: FOST 206 (W), ANNX 208 (M)
Credit hours: 2 semester hours

Course coordinators:
Worcester:
Dr. Ann Lynch, PharmD, RPh, AE-C
Professor of Pharmacy Practice
Office: DBEN 419
Office hours: By Appointment
Telephone: 508-373-5639
Email: ann.lynch@mcphs.edu
Preferred method of communication: email

Dr. Sheila Seed, PharmD, MPH, RPh

Professor of Pharmacy Practice
Office: FOST 235
Office hours: By Appointment
Telephone: 508-373-5622
Email: sheila.seed@mcphs.edu
Preferred method of communication: email
Manchester:
Dr. Cheryl Abel, PharmD, RPh
Associate Professor of Pharmacy Practice
Office: BASC 115
Office hours: By Appointment
Telephone: 603-314-1720
Email: cheryl.abel@mcphs.edu
Preferred method of communication: email

Course instructors:
Prof. Frederick M. Frankhauser, JD, RPh (Worcester)
Adjunct Professor of Pharmacy Practice
Office hours: Wednesdays 5:00-6:00pm and by appointment
Email: fred.frankhauser@mcphs.edu
Preferred method of communication: email

Prof. Robert J. Stout, BS RPh (Manchester)

Pharmacy/Operations Manager Northeast Pharmacy Services
Adjunct Professor of Pharmacy Practice
Office hours: Wednesdays 5:00-6:00pm and by appointment
Email: rjstoutrph@comcast.net
Preferred method of communication: email

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COURSE DESCRIPTION
This course introduces the student to the state and federal regulations that govern the practice of pharmacy.
Topics include but are not limited to the Food, Drug and Cosmetic Act; the Controlled Substances Act; the
Omnibus Budget Reconciliation Act; the Poison Prevention Act; and the Health Insurance Portability and
Accountability Act, as well as specific state rules and regulations.

TEXT/PRIMARY COURSE MATERIALS

Required:
Abood Richard R, Burns Kimberly A. Pharmacy Practice and the Law 8th edition
Pharmacy Law course packet- provided on Blackboard
TurningPoint Response Cards (Clickers) and active license
o The use of TurningPoint technology is at the discretion of course lecturers.
o For problems registering clickers on Blackboard contact the MCPHS University Information
Services Help Desk.
o For mechanical/physical problems with clickers contact TurningPoint at:
Website: http://www.turningtechnologies.com/
Email: support@turningtechnologies.com
Phone: 866-746-3015
MCPHS-approved calculator for exams

COURSE OBJECTIVES
The knowledge and skills taught in this course are consistent with the Center for the Advancement of
Pharmacy Education (CAPE) Educational Outcomes 2013 (available at:
http://www.aacp.org/Documents/CAPEoutcomes071213.pdf) and the School of Pharmacy
Worcester/Manchester Curricular Outcomes adapted from the CAPE Educational Outcomes 2013. A current
list of our adapted CAPE 2013 curricular outcomes can be found on the Blackboard course titled, BB_SOP_WM:
School of Pharmacy Worcester/Manchester.

To view the goals and objectives for this course please refer to the document titled Course Objectives posted
on the course Blackboard site in the Course Information content area.

ASSESSMENT OF STUDENT LEARNING AND TEACHING EFFECTIVENESS

The material in this course will be team-taught by adjunct faculty and faculty of the school of
pharmacy Worcester/Manchester.
Instructional strategies utilized in this course may include but are not limited to:
o Lectures incorporating innovative teaching styles and interactive classroom activities
o Assigned readings provided by instructors
o On-line assignments
o Large-group discussions
o On-line lecture(s)
Students will be responsible for arriving to class prepared to discuss topics during each class session
Material covered on exams or in assessments will be material covered in class and/or from assigned
readings, online lectures or as detailed by the instructor(s).
On-line assessments, in-class assessments, midterm exams and a cumulative final exam will be
administered. The exams may consist of a variety of question formats, including but not limited to,
multiple choice or fill-in- the-blank questions.
During this semester, this course will begin using ExamSoft to administer exams electronically.
Students must have laptop computers that meet ExamSoft requirements, and subscribe to ExamSoft.
Information about subscribing will be provided. ExamSoft quizzes or exams may replace part of the
above-listed paper exams. Information about those quizzes or exams will be provided well in advance.

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COURSE REQUIREMENTS
There will be two 55-minute exams during the semester and one cumulative final exam.
o Turning-point in-class assessments 2% (1% each)**
o Blackboard assignments (4) 20% (5% each)
o Exams (2) 24% each
o Cumulative Final Exam 30%

**The scores for all in-class assessments will be recorded

The final in-class assessment grade will be determined from the 2 highest scores from the completed
clicker assessments
Per the Department of Pharmacy Practice Class Attendance Policy, students are responsible for
bringing their clickers to class daily and making sure that their clickers are functioning
There will be no make-ups allowed for forgotten or malfunctioning clickers, no exceptions.

Grading Scale
92.45-100 A
89.45-92.44 A-
86.45-89.44 B+
82.45-86.44 B
79.45-82.44 B-
76.45-79.44 C+
72.45-76.44 C
69.45-72.44 C-
59.45-69.44 D
< 59.44 F

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 COURSE OUTLINE

Pharmacy Law Lecture Schedule Fall 2017

Wednesdays 3:05-4:55
(Subject to change without prior notice)

Date Topic Instructor Readings and in-class clicker Blackboard

assessments assignments/
Readings due must be Online lectures
completed before the beginning
of class
9/6/17 Orientation/Course Overview, Drug Frankhauser Reading(s): Chapter 1 and
Week 1 Law/History Chapter 2 (text)
Overview of FDA regulations and terms In-class clicker assessment:
Chapters 1&2
9/13/17 Federal Controlled Substances Act Frankhauser Reading(s): Chapter 4 and 5
Week 2 (text) and Pharmacist Manual
In-class clicker assessment:
Chapters 1&2
9/20/17 Federal Regulations of Medications: Frankhauser Reading(s): Chapter 3 (text)
Week 3 Dispensing, Compounding v. Manufacturing In-class clicker assessment:
Chapters 4&5
9/27/17 Federal Regulation of Pharmacy Practice Frankhauser Reading(s): Chapter 6 (text)
Week 4 (OBRA, HIPAA, Poison Prevention Packaging In-class clicker assessment:
Act, Medicare, Medicaid, Fraud, Waste and Chapters 3&6
Abuse)
10/4/17 Pharmacist Malpractice Liability and Risk Frankhauser Reading(s): Chapter 8 (text) Blackboard
Week 5 Management In-class clicker assessment: Assignment #1:
Chapter 8 Posted: 10/2 by 8 am
Due: 10/6 by 8 am
10/11/17 Exam 1 (3:05-4:00pm)
Week 6 Seminar (4:10-4:55pm)
10/18/17 MA: MGL Chapter 13 Section 22-25, MGL Frankhauser Reading(s): assigned handouts
Week 7 chapter 94C, MA Pharmacy Regulation 247 and posted information
CMR Sections 1-9 Stout
NH: Pharmacy Act RSA 318, Controlled Drug
Act RSA 318B
10/25/17 MA: MA Pharmacy Regulation 247 CMR Frankhauser Reading(s): assigned handouts
Week 8 Sections 10-16 Stout and posted information
NH: The Rules Process: how to get involved
and make a difference, Ph 100, Ph 200, Ph 300:
Board functions, Licensing
11/1/17 MA: DPH Regulations 105 CMR 720, 721, 722 Frankhauser Reading(s): assigned handouts Blackboard
Week 9 Midstream Interchange, Joint Policy on and posted information Assignment #2:
Prescribing and Dispensing Dextro- and Levo- Posted: 10/30 by 8 am
Amphetamines, MD Prescribing (Self Due: 11/3 by 8 am
Prescribing, Anabolic Steroids) Policies, MGL Stout
Chapter 112
NH: Ph 400, 600, 800: CE, Compounding,
LRDD, Technicians
11/8/17 Exam 2 (3:05-4:00pm)
Week 10 Seminar (4:10-4:55pm)

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11/15/17 MA: Long Term Care, MA Health Regulations Frankhauser Reading(s): assigned handouts
Week 11 NH: Ph 500, 700: Ethics and Standards of Stout and posted information
Practice; Ph 1000, 1100, 1200, 1300, 1400:
Emergency Contraception, Collaborative
Practice, Central Processing, Vaccine
Administration, Unused Drug Program
11/22/17 Thanksgiving Holiday ONLINE LECTURE Towle On-line lecture:
Week 12 USP <795>, USP
<797>, USP <800>
Blackboard
Assignment #3:
Posted: 11/13 by 8 am
Due: 11/17 by 8 am
11/29/17 MA: CQI Frankhauser Reading(s): assigned handouts
Week 13 NH: Ph 1500, 1600 (Prescription Drug Stout and posted information
Monitoring Program), Ph 1700s (CQI) and
Ph 1800 (Advanced Practice Technician),
Pharmacy Interns
12/6/17 MA and NH: Frankhauser Reading(s): assigned handouts Blackboard
Week 14 Seminar Stout and posted information Assignment #4:
Posted: 12/4 by 8 am
Due: 12/8 by 8 am

COURSE SPECIFIC POLICIES AND PROCEDURES

All assignments are to be submitted no later than the due date and time indicated in the syllabus and/or on
Blackboard. Unless prior approval has been received by the instructor, assignments not submitted by the due
time/date will result in a grade of zero (0). If you anticipate that you will not be able to submit an assignment
on the due date you must contact the instructor before the due date/time.

Grades for each assessment will be posted in the Blackboard grade center.

Students are expected to abide by the Universitys Academic Honesty Policy as outlined in the Student
Handbook and on the SOP-W/M Blackboard site on all assignments and assessments including all in-class
(Turning Point clicker) assessments.

Penalties for violations of the Academic Honesty Policy are as follows:

Academic dishonesty during any in-class assessments (including use of another students clicker) will
result in a 5% deduction from the final course grade
Academic dishonesty during an assignment or exam will result in no credit (0 grade) for the
assignment or exam

Penalties may be also be assessed for any act of professional misconduct and include, but are not limited to: a
lower grade for the work involved; no credit (0 grade) for the work involved; a lower grade for the course;
automatic failure of the course; and/or expulsion from the program.

Exam Dress Code: In addition to the exam dress code listed in the general SOP W/M Policies, scarves,
gloves/mittens, thumb-hole sleeves or any outerwear worn over the white coat are not permitted to be worn
during an exam.

Clickers: Each student must have a Turning Point "clicker," and is responsible for making sure that his/her
clicker is working and that he/she uses it every day in class. Students may not give their clickers to other
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students to click in for them. Doing this is a violation of the Student Code of Conduct. The penalty for such a
violation is described above. If a student is thought to have done this (given a clicker to another student, or
clicked in for another student), that student will be reported to the Dean of Students.

ExamSoft: The ExamSoft system will be used for some assessments during the semester (quizzes, exams). All
students must therefore have an active subscription to ExamSoft, and must download assessments to their
laptop computers as directed by the course instructor.

Any situations not addressed by the policies and procedures above will be handled at the discretion of the
instructor(s) or course coordinator(s).

Students will be assigned seats for the exams and the seating assignment will be posted outside the room prior
to the start of the exam. It is the responsibility of the student to determine his/her seat prior to the start of the
exam.

Exam Deductions
Only MCPHS University-approved calculators without covers are allowed to be used during exams.
Calculators may not be shared, so please plan accordingly. In the event that a student shares a
calculator, 10 points will be deducted from the exam score of each student involved.
Possession and/or use of cell phones, all watches or any other electronic or communication devices
during an exam will result in a minimum 10-point deduction from the exam score or possibly
resulting in a more severe penalty depending on the type of use. Any such device found in an exam
room will be confiscated and the student will be required to show the devices recent history (call,
text, etc.), open windows/applications, etc. to the proctor and/or course coordinator for potential
academic honesty violations; students using communication devices during an exam may not be
permitted to continue taking the exam in accordance with the SOP-W/M Academic Honesty During
Exams policy.
Entering/Exiting Exam Rooms: Late entry to the exam room (after the exam start time) is disruptive to
other students and unprofessional. It is also a violation of the Student Code of Conduct for Disrupting
the academic and or clinical pursuits of fellow students.
Students who arrive after the start-time of the exam, up to 10 minutes after that time, will incur a
2-point deduction on their total exam score. Students will also be required to record their name and
ID number on a sign-in sheet in the exam room. Students with two (2) or more late entries to exams,
regardless of course, during a semester will also be reported to the Dean of the SOP W/M. Students
will not be given any extra time to complete the exam or assessment. No student will be permitted to
enter an exam room later than 10 minutes after the beginning of the exam period.

Students will NOT be permitted to leave and return to the exam room during the exam. Students
should ensure that they bring all necessary supplies (see above) and to use the restroom before
entering the exam room. No student may leave the exam room earlier than 15 minutes after the
beginning of the exam. Students should not congregate and talk anywhere near the doors to exam
rooms after leaving the rooms, as long as the exam is still underway and/or if other classes are in
session.

When the exam is over, any students remaining in the exam room must stop writing or filling in
Scantrons and follow exam proctor instructions prior to leaving. All exams and Scantrons must be
given to the proctor by the end of the exam period. If a student does not turn in his/her exam and
Scantron on time, he/she risks receiving a score of zero (0) on the exam.

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Scantron Information
Students are responsible for correctly encoding Scantron sheets with student identifying information
including name, exam number, exam form (e.g. A or B), appropriate identification number, and all
corresponding bubble-fill-ins.
Students who fail to complete the academic honesty pledge on an exam or assessment will receive a
2-point deduction.
Students who fail to write their names and MCPHS University ID number on written assessments or
exams will not receive credit (will receive a score of zero) on the corresponding assessment or exam.
Errors in names or ID numbers will result in a 2-point deduction. If errors result in an inability to
identify the students work, no credit (zero score) will be given.
A 2-point deduction in the exam grade will occur for each error made in providing or omitting
personal information (i.e name, exam number, exam form, identification number, and corresponding
bubble fill-ins) on a Scantron sheet or if your Scantron cannot be processed for any reason.
A maximum of 10 points from each exam can be deducted due to errors or omissions of personal
information on Scantron forms.
Students are responsible for correctly transferring any answers marked on their exam to the Scantron
form. Answer bubbles must be filled in completely and accurately for the Scantron reader to function
appropriately and avoid any delays in the posting of scores. Scores posted are based on Scantron
entries only. Actual exams will not be compared to submitted Scantron forms for accuracy.

SOPW/M COURSE, EXAM AND GRADING POLICIES AND PROCEDURES

Students must abide by the School of PharmacyWorcester/Manchester (SOPW/M) Course, Exam and
Grading Policies and Procedures.

Important course information provided in these policies includes but is not limited to: Student Conduct,
Academic Honesty and Plagiarism, Attendance, Absence, Tardiness, Class Participation, Course
Communication, Distance Education Outages, Personal Audio Recordings, and School Closures.

Important exam and grading information provided in these policies includes but is not limited to: Exam Dress
Code, Exam Supplies, Entering/Exiting Exam Rooms, Exam Scantrons, Questions About/During Exams,
Academic Honesty During Exams, Absence from Examinations, Make-up Examinations, Exam Review
Guidelines, Posting of Exam Scores and Grading, and Final Course Grades.

To view the SOPW/M policies and procedures mentioned above please refer to the documents posted on the
Blackboard course titled, BB_SOP_WM: School of Pharmacy Worcester/Manchester.

UNIVERSITY POLICIES AND PROCEDURES

Students must abide by the Academic Policies and Procedures set forth in the MCPHS University Catalog.
Important information regarding Excused Absence Approval, Disability Support Services for students, Academic
Honesty and Plagiarism and other academic policies is set forth in the Academic Policies and Procedures
section of the current MCPHS University Catalog.

Additional campus specific academic policies and procedures are available in the current MCPHS University
Student Handbook. (The Catalog and Student Handbook are available online.)

Students must read, understand, and comply with all University, SOPW/M and course-specific policies and
procedures.